NCT05408767

Brief Summary

To explore whether brain volume loss (BVL) in people with multiple sclerosis (MS), assessed on magnetic imaging (MRI) data obtained during routine medical follow-up (and thus outside a standardized research environment), differs from that of healthy controls and correlates with measures of physical and/or cognitive disability, the latter also gathered during regular clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

June 2, 2022

Last Update Submit

June 7, 2022

Conditions

Retrospective Study

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort

    the difference in annualized whole brain volume measured by Icometrix

    4 - 5 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multiple Sclerosis

You may qualify if:

  • MRI and volumetry performed minimum 48 and maximum 60 months apart

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, 1820, Belgium

Location

Study Officials

  • Miguel D'haeseleer

    National MS center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

May 1, 2022

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)